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OpenTrials
Completed

NCT Number: NCT01122953

Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions

To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Mexico City, 14050, Mexico

About this study

Bioequivalence study in healthy volunteers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and/or female subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.

Treatment and study plan

Phenytoin

Drug

Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.

Epamin

Drug

Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC

Primary outcomes

  1. Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.

    Time frame: 0-168 h

  2. Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.

    Time frame: 0-168 h

  3. Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.

    Time frame: 0-168 h

Secondary outcomes

  1. Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time.

    Time frame: 0-168 h

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

Bioequivalence Study Of 5ml Dose Of PHENYTOIN 125mg/ 5ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus EPAMIN® 125 mg/5ml Made By McNeil LA LLC, Study In Healthy Volunteers Under Fasting Conditions

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 13, 2010
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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